Kornimate/medical-research-clean huggingface dataset:
the effects of mediterranean diet on remission, lipid profile, weight and body composition in children and adolescents with newly diagnosed type 1 diabetes

Conditions: Type 1 Diabetes

Summary: nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition. there is a growing body of evidence showing that mediterranean diet has a major role in prevention of diabetes sequelae in type 2 diabetes patients. hitherto, the effects of mediterranean diet on patients with type 1 diabetes has not been studied, with the exception of one italian study. six months after education to consume mediterranean diet in a cohort of 96 children with type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary fiber consumption, lower ldl cholesterol levels and better hdl to ldl cholesterol ratio. the proposed study is aimed to assess the impact of mediterranean nutrition compared to the accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid profile, metabolic control, c peptide, daily insulin dose, inflammatory parameters, endothelial function and anthropometric parameters 12 months following diagnosis. the study designed as a two parallel arms, randomized, single center, intervention study. patients enrolled to the study will be randomly assigned, to one of the following groups in a 1:1 ratio. interventional arm: patients assigned to the interventional arm will receive nutritional instructions of mediterranean diet and control group: patients assigned to the interventional arm will receive regular nutritional instructions in accordance with the accepted nutritional guidelines


Eligibility criteria:
inclusion criteria: * parents/guardian are willing and able to sign an informed consent form * age 5-18 years * diagnosis with type 1 diabetes for up to 2 months prior to screening * peak c peptide \> o.2 pmol/ml exclusion criteria: * the patient has any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator might interfere with patient's compliance or ability to complete the study * any concomitant disease that might impact body composition, physical activity level and/or eating habits * active celiac disease, hashimoto thyroiditis or uncontrolled graves' disease * down syndrome, turner, inflammatory bowel disease * patients treated with antipsychotic drugs, steroids, or other drugs that might affect body weight and appetite. * patient who suffers from eating disorders * patients participating in other device or drug studies

Keywords: type 1 diabetes newly diagnosed lipid profile mediterranean diet
role of high flow nasal oxygen as a strategy for weaning from invasive mechan

Conditions: Respiratory Failure With Hypoxia

Summary: evaluate the efficacy of high flow nasal oxygen as a weaning strategy in mechanically ventilated patients with respiratory failure.

acute respiratory failure is a main cause of imv and admission to intensive care unit (icu){1}. the day of extubation is a critical time during an intensive care unit (icu) stay because in case of postextubation failure {2},which reach to 25 - 40% from extubated patient associated with vap and barotrauma, mortality rate and hospital stay will increase , we use adjuvant oxygen therapy to prevent these undesirable event like cot ,niv and high-flow nasal cannula (hfnc) which can be used as an initial weaning strategy from imvdue to its physiologic benefits \[3-4\]. hfnc devices supply between 30 and 60 l/min of a controlled mixture of actively warmed (32-37 °c) and humidified (up to 100% relative humidity) oxygen and air through modified nasal prongs. producing {5-6-7}: 1. moderate positive end-expiratory pressure (peep) . 2. hfnc might help prevent extubation failure through different mechanisms: 1. first, the controlled oxygen concentration may reduce transient hypoxemic episodes . 2. second, the high flow washes the nasopharyngeal dead space, thus reducing co2 re-breathing; this effect reduces respiratory rate and minute ventilation . 3. third, the small amount of peep may reduce lung collapse . c)enabling better gas exchange and reduced work of breathing. d)in patients with chronic obstructive pulmonary disease (copd), this level of peep may counterbalance auto peep, further reducing the work of breathing. e) humidification may improve mucus drainage and reduce mucus retention, alleviating the associated atelectasis.

Eligibility criteria:
inclusion criteria: 1- all adult patients who were admitted to our icu requiring endotracheal intubation (eti), were eligible for the study. exclusion criteria: 1. non-intubated patients or those with tracheostomy were excluded from the study. 2. those having neurological alteration unrelated to hypercapnoeic encephalopathy, cranio-facial deformity, upper airway obstruction, cardiogenic pulmonary edema, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism, gastrointestinal bleeding, and post-operative respiratory failure. 3. patients less than 18 y.
influence of sarcopenia in hepatocellular carcinoma patients

Conditions: Sarcopenia

Summary: liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. locoregional therapies such as transarterial chemoembolization (tace), transarterial radioembolization (tare), and radiation are associated with improved survival and quality of life for patients with unresectable hcc \[couri and pillai, 2019\]. however, curative therapies or locoregional therapies are not applicable to approximately 50% of hcc cases who are diagnosed at an advanced stage and have progression with transarterial therapies \[park et al., 2015\]. for these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy \[fan et al., 2022\]. sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function \[cruz-jentoft and sayer, 2019\]. it has been associated with higher mortality among the general population and patients with cancer. this study aims to assess the possible role of sarcopenia in predicting the outcome of hcc patients following a variety of treatments including local ablation, tace and sorafenib.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of hepatocellular carcinoma. 2. treatment-naive patients who underwent local ablation, tace or sorafenib as a primary treatment . exclusion criteria: 1. use of other another hcc treatment modality e.g., resection. 2. use of combined treatments e.g., simultaneous use of embolic therapy with ablation. 3. patients with recurrent hcc. 4. patients with secondaries from extra-hepatic primary tumors. 5. incomplete data at the diagnosis, treatment or follow up time-points. 6. loss of patients follow up.
awbat versus biobrane in partial thickness burns

Conditions: Burns

Summary: • to determine if awbat, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, lower costs, and improved scarring and long term recovery when compared to biobrane®.

currently there is no "best covering" or a standard "approved care" for treating partial thickness burns. several options are available; however, they all have shortcomings. the application of topical antimicrobial dressings is time consuming and the regular dressing changes often associated with pain. homograft or cadaver skin is often unavailable or in great shortage for skin transplants. biobrane®, a biosynthetic wound dressing constructed of a silicone film with a nylon fabric partially imbedded into the film, has been available and used at our institute for many years as a skin substitute. it has been shown to reduce pain and the number of necessary dressing changes, and significantly reduced healing time (1). its main side effects, although rare, are the occasional occurrence of infections and allergic reactions to the material. recently, a new product, awbat, has been developed for the coverage of partial thickness burns. awbat is similar to biobrane® in terms of silicone membrane thickness, the structure of nylon fabric that gives the dermal substitute its strength, and the use of collagen peptides on the inner side of the membrane. these peptides are used for the purpose of reacting with the fibrin in the wound in order to achieve good initial adherence and to accelerate re-epithelialization. the key novelties of awbat are the different pore size and modality of collagen peptide attachments. these two key modifications aim at a reduction of the above mentioned adverse reactions. the purpose of this study is to compare awbat to biobrane® for covering partial thickness-burn injuries. we wish to determine if awbat, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, and improved scarring and long term recovery when compared to biobrane®.

Eligibility criteria:
inclusion criteria: * partial thickness burns between 4% and 40% total body surface area(tbsa) * full thickness burns not to exceed 10% tbsa, * age as specified exclusion criteria: * full thickness burns that require immediate excision and grafting * known allergic reaction against biobrane * chemical and electrical burns

Keywords: partial thickness burn biological dressing
preventive health behavior in women

Conditions: Colon Cancer

Summary: the overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.

the overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography and to develop an innovative approach for reducing barriers colorectal cancer screening in women, using screening mammography, an existing non-colon cancer related screening test that has widespread public acceptance, as a "teachable moment." although screening for colorectal cancer (crc) has been shown to decrease the incidence of crc and crc associated mortality, adherence to screening guidelines from the american cancer society and the american gastroenterological association remains poor.1-5 barriers to adherence are not fully defined, but may include poor understanding of the relative benefits and risks of crc screening, absence of physician recommendation, lack of insurance coverage for screening procedures, and poor patient acceptance of screening procedures. a potential challenge in increasing patient knowledge may be the milieu in which the educational intervention is administered. this study will be the first prospective study to evaluate the effectiveness of an educational intervention designed to increase crc screening administered at a cancer screening visit unrelated to crc.

Eligibility criteria:
inclusion criteria: 1. women between the ages of 50 and 75 years old. 2. scheduled for a screening mammogram. exclusion criteria: 1. crc screening current (fobt within preceding 12 months, fs within 5 years, or colonoscopy within 10 years). 2. family history of crc in a first-degree relative. 3. personal history of colonic adenomatous polyps, crc or inflammatory bowel disease
promoting activity in cancer survivors

Conditions: Physical Activity; Breast Cancer

Summary: a randomized multi-component physical activity intervention for breast cancer survivors.

the research project is a study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors. individuals meeting inclusion/exclusion criteria will be randomized to one of sixteen intervention groups for the 6 months. intervention components will include print-based education, self-monitoring, active living counseling, supervised exercise sessions, and facility access. blood samples will be collected at baseline. assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (weeks 13 and 25). changes in physical activity will be assessed for each intervention group.

Eligibility criteria:
inclusion criteria: * breast cancer survivors between 3 months and 5 years post-treatment * report \<150 minutes of moderate-to-vigorous physical activity (mvpa) on the gpaq * physically able to engage in physical activity exclusion criteria: * medical condition contraindicating physical activity participation * cognitively unable to give informed consent
a phase i/ii clinical trial for treatment of aromatic l-amino acid decarboxylase (aadc) deficiency using aav2-haadc

Conditions: Aromatic L-amino Acid Decarboxylase (AADC) Deficiency

Summary: this phase i/ii trial is to prove the efficacy and safety of aav2-haadc to treat patients with aadc deficiency.

aromatic l-amino acid decarboxylase (aadc) is an enzyme responsible for the final step in the synthesis of neurotransmitters dopamine and serotonin. aadc deficiency is a rare genetic disorder. taiwanese carry a high prevalence of aadc deficiency due to the founder mutation ivs6+4 a\>t, and patients usually die before the age 5-6 years due to severe motor dysfunction. gene therapy with adeno-associated virus (aav) serotype 2 (aav2) driven human aadc (haadc) has been tested in both animal models and phase i clinical trials of parkinson disease. we have done a compassionate treatment of 8 patients with aadc deficiency by aav2-haadc and demonstrated a result that among the treated patients, 4 could stand with support, 3 could sit with support, and there was no virus-associated toxicity. the longest follow up has exceeded 4 years. this study is to prove the safety and efficacy of aav2-haadc treatment for patients with aromatic l-amino acid decarboxylase (aadc) deficiency.

Eligibility criteria:
inclusion criteria: 1. with a confirmed diagnosis of aadc, including cerebrospinal fluid analysis to show reduced levels of neurotransmitter metabolites, hva and 5-hiaa, and higher l-dopa, together with more than one mutation within aadc gene. 2. classical clinical characteristics of aadc deficiency, such as oculogyric crises, hypotonia and developmental retardation. 3. the sick child has to be over 2 years old or a head circumference big enough for surgery. 4. participating patients must cooperate completely for all evaluations and examinations before, during and after the whole trial. 5. parents or guardians must sign to agree on this informed consent. exclusion criteria 1. significant brain structure abnormality 2. patients with any health or neurological doubts that may increase the risk of surgery cannot join this trial. pi has the right to evaluate the feasibility of subjects for this trial based on his/her health condition. 3. since high-level neutralizing antibodies may disturb the therapeutic effect of gene therapy, patients with anti-aav2 neutralizing antibody titer over 1,200 folds or an elisa od over 1 cannot be enrolled into this trial. 4. subjects enrolled in this clinical trial cannot take any medications that may affect this trial.

Keywords: aromatic amino acid decarboxylase aadc ddc gene therapy aav2-aadc viral vector gene transfer aromatic l-amino acid decarboxylase deficiency
hemin to prevent post-ercp (endoscopic retrograde cholangiopancreatography) acute pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: ercp (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. however, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. some patient groups have been demonstrated to present a higher risk linked to individual factors or to the procedure. some interventions (endoscopic or pharmacologic) have been evaluated to reduce the incidence of this complication but each has his own inconvenient. recently, the activation of heme oxygenase (ho) by intraperitoneal administration of hemin has been demonstrated to be effective in prevention and treatment of acute pancreatitis mice models. this protective effect has been associated to intrapancreatic ho-1 positive macrophage recruitment activated by hemin. the investigators thus propose to conduct a prospective randomized double blind controlled trial to demonstrate a protective effect of hemin administration against post-ercp acute pancreatitis in high risk patients.

patients for who a pancreatic stent placement is indicated will be excluded from the study. the aims of this study are: 1) to study in a pathophysiologic point of view the activation of ho-1 by hemin in human and its protective effect in post-ercp acute pancreatitis incidence. 2) to use the human situation of post-ercp acute pancreatitis as early pancreatitis model to study the administration of hemin as treatment of acute pancreatitis in general.

Eligibility criteria:
inclusion criteria: one or more factors of \>10% post-ercp acute pancreatitis risk: * former episode of acute pancreatitis * former episode of post-ercp acute pancreatitis * normal bilirubin level * main pancreatic duct injection * endoscopic biliary sphincteroplasty (balloon dilation of biliary sphincter) * precut papillotomy * pancreatic sphincterotomy exclusion criteria: * patient for whom a pancreatic stent is inserted (sphincter of oddi dysfunction, ampullectomy) * ongoing acute pancreatitis * chronic pancreatitis (cremer classification \>=2) * age \< 18 y/o * pregnancy * hemin allergy * severe renal failure (mdrd\<30ml/min/1.73m2)

Keywords: ercp virgin papilla risk of post-ercp acute pancreatitis
rates and risk factors of contact between the otx-tic intracameral ocular implant and corneal endothelium

Conditions: Corneal Endothelium

Summary: to determine what proportion of patients have inferior angle recess dimensions that could accommodate the otx-tic, and what are risk factors for implant contact with the corneal endothelium.


Eligibility criteria:
inclusion criteria: * age over 40 years * no history of ocular surgery other than cataract surgery exclusion criteria: - media opacities that preclude oct imaging of the anterior segment
workload in anesthesiological practice

Conditions: Work Related Stress

Summary: the study evaluates differences in perceived and objective workload in anesthetists during intubation procedure with a direct (mcintosh) or indirect (glidescope) laryngoscope. expert anesthetists will perform 3 intubations per device, while completing a secondary task, during which reaction times to an auditory stimulus will be recorded, and will complete a questionnaire (the nasa-task load index) to evaluate their perceived workload at the end of each procedure.

intubation and laryngoscopy are the most demanding procedure in anesthesiological routine clinical practice, associated with high workload. the measurement and management of workload is considered important in anesthesiology to prevent work-related stress and errors in performance. new devices, thanks to advances in technology, seem promising in reducing operators' workload and improving safety and success of intubation processes. therefore, in this study, based on previous results, the hypothesis that the glidescope videolaryngoscope reduces operators' perceived and and objective workload, as compared to the standard mcintosh laryngoscope, will be tested. expert anesthetists will perform 3 intubations per device in a randomized order, while completing a secondary task, during which reaction times (verbal responses) to an auditory stimulus (a clacson) will be recorded, and operators will complete a questionnaire (the nasa-task load index) to evaluate their perceived workload at the end of each procedure.

Eligibility criteria:
inclusion criteria: * anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate exclusion criteria: * anesthetists that refuse to participate * anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate * anesthetists that have left hearing loss

Keywords: mental workload anesthesia laryngoscopy intubation perceived workload
the omeza protocol for chronic ulcers

Conditions: Venous Leg Ulcer; Diabetic Foot Ulcer

Summary: this study will compare the omeza® products bundle to standard of care (soc) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.

this is a randomized, multi-center, open-label study comparing the omeza® products bundle versus standard of care treatments for 2 different types of chronic ulcers (venous leg ulcers and diabetic foot ulcers). the treatment period will be 12 weeks, with subjects coming into the study site weekly for evaluations, photography and formal measurements of the target wound, and dressing changes. there will be a total of 13 study site visits. the screening visit (day 0) will occur 1 week prior to randomization and will include routine labs and vascular assessment to determine inclusion/exclusion of the potential subject from the study; followed by weekly treatment visits (week 1 through week 11); randomization will occur at treatment visit week 1; the treatment visit week 12/end of study visit will include end of study labs. target wounds will be photographed and measured, and vascular assessment will be done at each of the 13 visits. if the wound closes before week 12, the subject will continue to come in for all the remaining study visits until study completion. if the wound does not close by week 12, the subject will be immediately exited from the study and no further follow-up will occur as part of the study.

Eligibility criteria:
inclusion criteria: 1. male or female 21-80 years of age 2. participated in the informed consent process and signed study specific informed consent document 3. willing and able to comply with study procedures, including study visits and study dressing regimens 4. confirmation of venous disease by non-invasive venous studies with either doppler- confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema). biopsy done to exclude other skin conditions e.g. cancer on ulcers ≥ 6 months 5. hba1c of ≤ 10% 6. have a venous ulcer between the knee and ankle, at or above the malleolus 7. for vlu's: target wound size ≥ 4 cm2 to ≤ 150 cm2 in area without exposed tendon, muscle or bone for dfu's: target wound size ≥ 0.25 cm2 to ≤ 150 cm2 post debridement at screening visit and treatment visit week 1/randomization 8. target wound duration of at least 3 months and less than or equal to 12 months as of the date the subject signs consent for study 9. containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue 10. be willing and able (or have family member/friend willing and able) to apply required dressing changes as well as the ability of the subject to tolerate limb compression bandage 11. ankle-branchial index (abi) less than 0.80 or greater than 1.3 exclusion criteria: 1. subjects with a bmi ≥ 65 2. subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having alzheimer